Pda book table of contents-environmental monitoring a comprehensive handbook volume 7-2015

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<ol><li> 1. www.pda.org/bookstore </li><li> 2. ENVIRONMENTAL MONITORING A Comprehensive Handbook JEANNE MOLDENHAUER Editor Volume Seven PDA Bethesda, MD, USA DHI Publishing, LLC River Grove, IL, USA 01Front Matter:FrontMatter 11/12/14 19:19 Page 1 www.pda.org/bookstore </li><li> 3. 10 9 8 7 6 5 4 3 2 1 ISBN: 1-933722-85-1 Copyright 2015 J. Moldenhauer All rights reserved. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system or transmitted in any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America. Where a product trademark, registration mark, or other protected mark is made in the text, ownership of the mark remains with the lawful owner of the mark. No claim, intentional or otherwise, is made by reference to any such marks in the book. The authors have made every effort to provide accurate citations. If there are any omissions, please contact the publisher. While every effort has been made by the publisher and the authors to ensure the accuracy of the information expressed in this book, the organization accepts no responsibility for errors or omissions. The views expressed in this book are those of the editors and authors and may not represent those of either Davis Healthcare International or the PDA, its officers, or directors. This book is printed on sustainable resource paper approved by the Forest Stewardship Council. The printer, Gasch Printing, LLC, is a member of the Green Press Initiative and all paper used is from SFI (Sustainable Forest Initiative) certified mills. PDA Davis Healthcare International Publishing, LLC 4350 East West Highway 2636 West Street Suite 200 River Grove Bethesda, MD 20814 IL 60171 United States United States www.pda.org/bookstore www.DHIBooks.com 001-301-986-0293 01Front Matter:FrontMatter 11/12/14 19:19 Page 2 www.pda.org/bookstore </li><li> 4. CONTENTS Introduction xiii CLEANROOMS AND PREVENTING CONTAMINATION 1 INTRODUCTION TO CLEANROOM DESIGN AND OPERATION 3 Tim Sandle Introduction 3 Cleanrooms 3 Clean air devices 5 Cleanrooms and Contamination Control 6 Risk assessment 10 Cleanroom Classification 10 Particle counting 16 Cleanroom Operational Parameters 17 Air filtration 18 Air-patterns and air-movement 19 Airflow velocity and direction 20 Air changes 20 Clean up times 21 Separation concept and positive pressure differentials 21 Other factors 21 iii 02Contents:Layout 1 11/12/14 19:38 Page iii (Black plate) www.pda.org/bookstore </li><li> 5. Cleanroom Design 22 Energy saving 22 Cleaning and Disinfection 22 Environmental Monitoring 23 Auditing 24 Conclusion 25 References 26 About the Author 27 2 PROTECTING CLEANROOMS FROM CONTAMINATION 29 Jeanne Moldenhauer Introduction 29 Types of Particulates 29 Size of Particulates 30 Recommended Practices 31 Cleanroom Standards 32 Cleanroom Design 33 Cleaning and Disinfection 34 Preventative Maintenance 34 Good Housekeeping Practices 35 Clean in Place, Steam in Place, Sterilize in Place Systems 35 Humans are the Biggest Source of Contamination 35 Cleanroom Garments 37 Personnel Behaviors 37 Cleanroom Personnel and Smoking 38 Conclusion 39 References 39 About the Author 41 3 CLEANROOM GOWNING AND GOWNING CERTIFICATION 43 Jan Eudy Introduction 43 A Short Course in Particulation 43 Facility Design 44 Human Sourced Contamination 46 Behavior 47 Cleanroom Garments 48 Fabric and Findings 49 Type, Style and Construction of Garments 50 Garment Cleaning Process 51 Testing of Cleanroom Garments 52 Sterile Cleanroom Garments 55 Gamma Subcontractor Qualification 56 Routine Monitoring of Gamma Radiation 56 Environmental Monitoringiv 02Contents:Layout 1 11/12/14 19:38 Page iv (Black plate) www.pda.org/bookstore </li><li> 6. Certificate of Sterility 56 Gowning for the Cleanroom 57 Sterile Gowning Procedure for ISO Class 35/Class A Cleanrooms 57 Donning 57 Doffing 58 Non-Sterile Gowning Procedure for ISO Class 35 Cleanrooms 58 Donning 58 Doffing 59 Gowning Procedure for Frocks in ISO Class 68 Cleanrooms 59 Donning 59 Doffing 60 Gowning Certification 60 Summary 61 References 61 About the Author 63 4 CLEANING AND DISINFECTING CLEANROOMS 65 Jim Polarine, Elaine Sartain, and Carol Bartnett Introduction 65 Disinfectant Selection 66 References 72 About the Authors 73 5 STERIPLEX,A NEW SILVER-BASED DISINFECTANT NON-CORROSIVE, NON-TOXIC, SPORICIDAL: DISINFECTANT EFFICACY EVALUATIONS 75 John M. Lindsay Summary 75 Introduction 76 Materials and Methods 77 Neutralizer broth 77 Procedures 78 Results 83 In Situ Evaluations 85 Additional tests 86 Conclusions and Discussion 88 References 89 About the Author 90 Attachment 1 Project Protocol 91 Attachment 2 Enumeration of Challenge Microorganism Suspensions 100 Attachment 3 Preparation of Steriplex Neutralizer Broth 102 Attachment 4 Data Sheet for Steriplex Challenge 103 Attachment 5 Pour Plate or Spread Plate Method for Total Aerobic Microbial Count 113 Contents v 02Contents:Layout 1 11/12/14 19:38 Page v (Black plate) www.pda.org/bookstore </li><li> 7. 6 OZONE GAS: DECONTAMINATION, SANITIZATION AND STERILIZATION 115 Brian G. Hubka and Jeanne Moldenhauer Introduction 115 What is Ozone and how does it Work? 116 Ozone generators 116 Using ozone 116 Ozone to inactivate microorganisms 117 Safety concerns using ozone 117 Concerns using ozone technology 118 Ozone benefits 118 Compatibility of Ozone with Other Materials 119 Using Ozone as a Sterilant 120 Microbiological Aspects of Ozone Use 121 Pharmaceutical Applications for Gaseous Ozone Usage 123 Conclusion 123 References 123 About the Authors 125 7 STERILIZATION AND DECONTAMINATION WITH NITROGEN DIOXIDE GAS 127 David Opie Introduction 127 NO2 Physical Properties 127 Safety 128 Mechanism of Action 130 Response of microorganisms to NO2 131 Inactivation kinetics 132 Cycle Parameters 133 NO2 Cycle Descriptions 137 Vacuum NO2 cycles 138 Non-vacuum NO2 cycles 139 Material Compatibility 139 Chemical compatibility 140 Biocompatibility 141 Sterilizability on materials 142 Process Accessories 143 Biological indicators 143 Process challenge devices 144 Chemical indicators 144 NO2 concentration detectors 145 Humidity detector 145 Applications for the NO2 Technology 145 NO2 application to prefilled syringes and drug containers 145 Terminal sterilization of medical devices 147 Environmental Monitoringvi 02Contents:Layout 1 11/12/14 19:38 Page vi (Black plate) www.pda.org/bookstore </li><li> 8. Decontamination of filling lines and isolators 148 Summary 149 References 149 About the Author 151 ENVIRONMENTAL MONITORING TECHNIQUES AND METHODS 8 SETTING UP AN ENVIRONMENTAL MONITORING PROGRAM FOR CONTROLLED ASEPTIC CLEANROOM ENVIRONMENTS 155 Ryan Burke and Francis McAteer Introduction 155 Design and Assessment of the Cleanroom Facility 157 How does a cleanroom accomplish control? 157 Determining Appropriate Sampling Methodologies 162 Environmental monitoring general overview 162 How the air is sampled in a cleanroom 163 How surfaces are sampled in a cleanroom 163 How personnel are monitored in a cleanroom 163 Monitoring and Sampling Techniques 164 Generating SOPs and Protocols 169 Sampling Plan Design 170 Data Management 172 Establishing Alert and Action Limits 173 Corrective Action and Preventative Action Process 176 Importance of Maintaining and Conducting the Environmental Monitoring Program Properly 177 Conclusion 177 References 178 About the Authors 180 9 QUALITY RISK MANAGEMENT SAMPLING PLAN A VALIDATION ENGINEERING PERSPECTIVE 181 Allan Marinelli Introduction 181 Purified Water System 182 Quality Risk Management 182 Rationale for Determining the PQ Sample Points 183 Conclusion 201 References 201 About the Author 202 Contents vii 02Contents:Layout 1 11/12/14 19:38 Page vii (Black plate) www.pda.org/bookstore </li><li> 9. 10 PRACTICAL APPROACH ON THE EFFICIENCY OF MICROBIOLOGICAL METHODS FOR ENVIRONMENTAL MONITORING 203 Anne-Grit Klees and Reinder Hedderich Fertility: Growth Promotion Test 205 Growth Promotion Tests in the Presence of Inhibitory Substances 208 Overall Efficiency of Surface Sampling Methods 212 References 216 About the Authors 218 11 OPTIMIZING TIME-TO-RESULTS FOR ENVIRONMENTAL MONITORING APPLICATIONS FOR GROWTH-BASED RAPID MICROBIOLOGY METHODS 219 Andrew Sage Time-to-results and Incubation Profiles of Environmental Monitoring Testing Applications 219 TTR: An Important Requirement for Growth Based Rapid Micro Methods 220 Requirements for Performing a TTR Determination on Growth-based RRMs 220 Experimental Strategy for Optimizing Incubation and Setting TTR 221 Determining Optimal Incubation Profile and TTR for EM Testing on the Growth Direct System: An Automated, Growth-based RRM 221 Optimal Incubation Regime for Detection of Bacteria and Mold Species on the Growth Direct System 224 TTR Determination for Serial Incubation on the Growth Direct System and Verification Testing 228 A Single Temperature Alternate Incubation Strategy may Replace Serial Incubation 230 Summary 232 References 232 About the Author 234 12 REAL-TIME RISK ASSESSMENT CONTROL STRATEGY 235 Sean Toler Real-time Risk Assessment Shaped from Quality by Design 235 QbD Risk Assessments to Develop RTRA 237 QbD Design Space Impact on RTRA 238 QbD Control Strategy of RTRA 239 Continuous Improvement from RTRA 241 Implementing the RTRA 244 Microbiologist Development for RTRA 252 Cultural Improvement from RTRA 253 Environmental Monitoringviii 02Contents:Layout 1 11/12/14 19:38 Page viii (Black plate) www.pda.org/bookstore </li><li> 10. Summary 254 References 254 About the Author 256 13 ENVIRONMENTAL MONITORING OF COMPRESSED GASES 257 Tim Cser and Anne Connors Introduction 257 Regulations and Guidance 257 Uses of Compressed Gas 259 Compressed Gas Testing 259 Bacteria Yeast and Mold 259 ISO 8573-4 Test Methods for Solid Particle Content 260 ISO 8573-7 Test Method for Viable Microbiological Contaminant Content 261 Alternative Viable Testing Methods 262 MAS-100 CG EX 262 RCS with CG adapter 262 Results Interpretation and Data Analysis 263 Investigations and Corrective Actions 263 References 264 About the Authors 264 14 ENVIRONMENTAL MONITORING FOR STERILITY TEST ISOLATORS 265 Claire Fritz Briglia History of Isolators for Sterility Testing 265 The Regulations 268 Installation Qualification/Operation Qualification 269 Performance Qualification 269 Why Establish an Environmental Monitoring Program for a Sterility Testing Isolator? 270 What to Monitor and What are the Methods? 271 Non-viable Air 271 Viable Air 272 Surface Monitoring 272 Glove Monitoring and Testing 274 Monitoring Outside the Isolator 275 When? 275 Action and Alert Levels 276 Culture Media for Environmental Monitoring 276 Validation 277 Conclusion 278 References 278 About the Author 279 Contents ix 02Contents:Layout 1 11/12/14 19:38 Page ix (Black plate) www.pda.org/bookstore </li><li> 11. CHANGES TO STANDARDS 15 TESTING AND VERIFICATION OF VENTILATION SYSTEMS FOR BIOSAFETY LEVEL 3 (BSL-3) AND ANIMAL BIOSAFETY LEVEL 3 (ABSL-3) FACILITIES 283 Farhad Memardazeh and Louis DiBerardinis Introduction 283 Definitions 285 What is Laboratory Biocontainment? 286 History of ANSI/ASSE Z9.14 288 What is ANSI/ASSE Z9.14? 290 Findings of the Gap and Needs Analysis 291 National US and local laws, standards and guidelines 292 National initiatives outside the US 295 International initiatives 296 ANSI/ASSE Z9.14: The Standard 297 How to read the standard 297 Purpose 297 Scope 297 Definitions 298 Applicability and conformance 298 Procedure for entities using the ANSI/ASSE Z9.14 Standard 299 Overview 300 Roles and responsibilities 302 Risk assessment 303 Guidelines for Implementing Testing and Performance-Verification 305 Verification 305 Documentation overview 305 Visual inspection 307 Testing methodologies 307 References 318 About the Authors 322 NEW TECHNOLOGIES FOR ENVIRONMENTAL MONITORING AND AIDS TO EVALUATING THEM 16 STRESSED MICROBIAL POPULATIONS: REAL-WORLD CHALLENGE FOR VALIDATION OF NEW APPLICATIONS 325 Andrew Sage Importance of Use of Stressed Microbial Populations for Validation Testing in Industry 325 Microbes in the Environment Exist in a Stressed State 326 Stress and Injury Response in Microbes 327 Environmental Monitoringx 02Contents:Layout 1 11/12/14 19:38 Page x (Black plate) www.pda.org/bookstore </li><li> 12. Preparation of Stressed Populations for Method Validation 329 Case study 1 Preparation of heat-injured spores of A. brasiliensis spores 330 Case study 2 Preparation of an acid-stressed population of Pseudomonas aeruginosa 332 Using the Growth Direct System to Measure the Effect of Stressed Induced Injury on the Growth Dynamics of Microbial Populations 332 Stressed Populations Exhibit Attenuated Detection as Exemplified by Heat-stressed A. Brasiliensis, and Acid-injured P. Aeruginosa 336 The Physiological State of a Test Organism can Influence its Response to Stress 337 Conclusion 338 References 339 About the Author 340 17 REAL TIME MICROBIAL ANALYZER FOR WATER 341 J.P. Jiang Technical Description of RMS-Water Analyzer 342 Validation Test of RMS-W Using BioBall 344 BioBall quantitative samples 344 Validation Test Data and Method Descriptions 346 Ruggedness test procedure 350 Miscellaneous suggestions for conducting feasibility study of RMS-W instrument 351 Application Example: Online Water Monitoring Using RMS-W 352 Example 1: RMS-W online monitoring of a high purity water line 352 Example 2: RMS-W online monitoring at a mineral water bottling plant 353 Application Example: Surface Sampling and Cleaning Validation 355 Example 1: surface sampling using RMS-W and Quantiswab 355 Example 2: cleaning validation using RMS-W and Quantiswab 357 Summary 358 References 358 About the Author 359 Appendix 361 Index 371 Contents xi 02Contents:Layout 1 11/12/14 19:38 Page xi (Black plate) www.pda.org/bookstore </li><li> 13. 02Contents:Layout 1 11/12/14 19:38 Page xii (Black plate) www.pda.org/bookstore </li><li> 14. INTRODUCTION This is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental monitoring. The appendix describes the various topics and authors that can be found in volumes 1 through 6 of this series. One of the first topics discussed in this volume is the topic of cleanrooms and ways to prevent contamination. This is important as an industry and we are changing the paradigm from reacting to contamination to a mode of preventing contamination. Dr. Tim Sandle provides a great guide to cleanrooms. This is followed by a discussion of methods to protect cleanrooms from contamination. Jan Eudy describes the methods to be used for gowning and gowning qualification to protect from contamination. Jim Polarine and his group have written a discussion on the cleaning and disinfection of cleanrooms. As we are always looking for new and/or better ways to do things, John Lindsay has a chapter on the qualification of a new disinfectant. This disinfectant is effective with approximately one minute of cont...</li></ol>